US10159571B2 - Device and method of treating heart valve malfunction - Google Patents

Abstract

An assembly and method for treating heart valve malfunction including mitral regurgitation wherein an elongated chord is movably disposed within an introductory sheath and an anchor is secured to a distal end thereof. The sheath and the chord are introduced into the heart chamber and penetrate and pass through the anterior mitral valve leaflet and preferably through the mitral valve orifice. The sheath and the chord are then extended transversely across the heart chamber and the distal end of the chord is anchored to an opposing portion of the heart wall. The sheath is withdrawn back along the length of the anchored chord through the anterior mitral valve leaflet and the proximal end of the chord is secured to the valve leaflet. The chord is secured under sufficient tension to maintain an intended positioning of the valve leaflet to overcome mitral regurgitation.

Description

CLAIM OF PRIORITY

The present application is a continuation in part of U.S. patent application Ser. No. 13/691,087, filed Nov. 30, 2012, which claims the benefit under 35 U.S.C. Section 119(e) of Provisional Patent Application Ser. No. 61/729,152, filed Nov. 21, 2012, and which is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention is directed to an instrument assembly and method of use and application in the treatment of heart valve malfunction. In more specific terms the instrument assembly is specifically adapted to treat mitral regurgitation by means of a direct entry of the instrument through the atrial wall rather than through the vascular system, in order to apply sufficient tension to a prolapsing leaflet, including the anterior leaflet and/or the posterior leaflet of the mitral valve, in order to overcome mitral regurgitation.

Description of the Related Art

The human heart is a four chambered pump that moves blood efficiently through the vascular system. During normal operation, blood enters the heart through the vena cava and flows into the right atrium. Thereafter, blood flows from the right atrium through the tricuspid valve and into the right ventricle. Upon contraction of the right ventricle, blood is forced through the pulmonic valve and into the lungs for oxygenation. The oxygenated blood returns from the lungs and enters the heart through the left atrium and passes through the mitral valve into the left ventricle. Upon contraction of the left ventricle the blood therein flows through the aortic valve and into the aorta and throughout the vascular system.

The mitral valve is disposed in flow regulating communication between the left atrium and the left ventricle. It is composed of two valve leaflets, the mitral valve annulus, which forms a ring that supports the valve leaflets; papillary muscles, which tether the valve leaflets to the left ventricle wall, by preventing them from prolapsing back into the left atrium. Chordae tendineae serve to connect the mitral valve leaflets to the papillary muscles thereby further preventing the leaflets from prolapsing back into the left atrium. A dysfunction of any of these components of the mitral valve can cause “mitral regurgitation”. Mitral regurgitation is a disorder of the heart in which the mitral valve does not close properly when the heart pumps out blood. This results in abnormal leaking of blood from the left ventricle back into the left atrium, through the mitral valve, when the left ventricle contracts and is a condition known as “mitral regurgitation”. It is generally recognized in the medical profession that mitral regurgitation is the second most common form of valvular heart disease.

As generally set forth above, when properly functioning, the anterior and posterior valve leaflets of the mitral valve overlap during contraction of the left ventricle and prevent blood from flowing back into the left atrium. This overlap of the 2 leaflets leaning upon each other is called the coaptation and absorbs most of the strain on the mitral apparatus during the ventricular contraction. However, when the mitral valve malfunctions, due to various cardiac diseases, the leaflets are no longer coapting resulting in the mitral valve remaining partially open during ventricular contraction. In turn this allows the “regurgitation” of the blood back into the left atrium, as generally set forth above. When the mitral valve does not close hermetically during the ventricular contraction, the aforementioned back flow of blood to the atrium and the pulmonary vasculature, results in a deleterious condition. More specifically, this condition increases the work load to the heart and may lead to heart failure.

Methods of treating conditions relating to the malfunctioning of the heart valve specifically including valve incompetencies, mitral valve leakage and other heart failure conditions may be in various stages of development, such as the extending of an elongate member transverse across a corresponding or affected heart chamber. Each end of the elongate member extends through a wall of the heart such as the septum wall and an oppositely disposed wall portion, wherein first and second anchoring members are connected to corresponding ends of the elongate member but are disposed external of the heart chamber. Connecting clips or the like are applied to the corresponding exterior ends of the elongate member, resulting in the papillary muscles within the chamber to be effectively re-shaped or repositioned. A predetermined force is applied to the heart itself and/or the affected portions of the heart chamber.

Other specific treatments associated with mitral regurgitation sometimes may include the surgical repair or replacement of the mitral valve, resulting in traumatic and frequently dangerous surgical procedures being performed on a patient.

Accordingly, there is a need in the medical arts for appropriate instrumentation and attendant methods of overcoming heart valve malfunctions, specifically including mitral regurgitation.

SUMMARY OF THE INVENTION

The present invention is directed to an instrument assembly and attendant method for treating heart valve malfunction. In more specific terms, the instrumentation and method are specifically, but not exclusively, adapted for the treatment of mitral regurgitation. However, for purposes of clarity and in order to emphasize the versatility of the various embodiments of the present invention, the subject instrument assembly and method will be described generically regarding treatment of a predetermined heart valve. In addition, the present invention will be more specifically described in regard to a procedure involving correction of a prolapsing mitral valve leaflet, which may include the anterior mitral valve leaflet and/or the posterior valve leaflet correcting of mitral regurgitation.

Accordingly, the instrument assembly of the present invention includes an introductory sheath formed of a material of sufficient rigidity to facilitate the penetration and passage through various portions of the heart and mitral valve. As such, the introductory sheath may be said to be formed of at least a “semi-rigid” material. However, this term is to be understood to include material having sufficient flexibility to be manipulated or “steered” through and/or along a predetermined path during the delivery of the sheath and associated components of the instrument assembly to predetermined portions of the heart. Moreover, in one preferred embodiment the sheath will be sufficiently maneuverable to pass through the atrial wall into interior portions of the heart such as the left atrium and left ventricle. In addition and as described in greater detail hereinafter, an introduction assembly and a delivery catheter will be used to facilitate the positioning the introductory sheath into the thoracic cavity and through the atrial wall or other preferred exterior locations of the heart wall.

Additional structural operative features of the instrument assembly include the provision and utilization of at least one, or under required circumstances, more than one elongated chord formed of a biocompatible material and being at least partially flexible. The material from which the chord is formed should have sufficient and/or predetermined tensile strength to exert a predetermined tension on the predetermined, prolapsing valve leaflet as the chord extends between a corresponding portion of the heart wall, such as the ventricular wall, as also more fully described hereinafter. The chord is initially housed concentrically within the interior of the introductory sheath, wherein the sheath and the chord are concurrently movable relative to the heart as well as throughout a portion of the interior thereof. As set forth above, the introductory sheath is formed of a material having physical characteristics that allow it to be accurately manipulated so as to be steerable in such a manner that its tip can aim towards the different designated portions of the anterior or posterior mitral valve leaflets that are in the siege of the prolapse.

Also, the exteriorly concentric introductory sheath is movable relative to and along the length of the chord so as to accommodate proper and intended placement and anchoring of the chord within the heart chamber. Therefore, the sheath is movable with the chord into and through predetermined portions of the heart chamber and movable relative to the chord after proper anchoring, securing and/or intended placement of the chord within the heart chamber. Accordingly, the instrument assembly of the present invention also includes an anchor secured to an outer or distal end of the chord. The anchor may also be sufficiently sharpened, pointed or otherwise configured to penetrate an intended heart valve leaflet, such as a prolapsing leaflet of the mitral valve. Further, the penetration and passage of the anchor, the chord, and the introductory sheath substantially through the predetermined valve leaflet may thereby be facilitated.

When properly positioned, the anchor is structured to be secured to a substantially opposing portion of the heart wall, such as the ventricular wall associated with the left ventricle and/or the papillary muscles associated therewith. In order to assure secure anchoring of the distal end of the chord with the corresponding ventricular wall, a gripping structure may be operatively attached to a remainder of the anchor and disposable into an outwardly and/or radially extending orientation. When so disposed, the gripping structure, in combination with the remainder of the anchor, eliminates or significantly restricts the inadvertent detachment of the anchor, and the distal end of the chord attached thereto, from the corresponding ventricular wall portion. In at least one preferred embodiment of the present invention, the anchor and the gripping structure are disposed and applied so as to penetrate the corresponding portion of the ventricular wall but not extend there through. Therefore, the anchored relation of the gripping structure, anchor and the connected distal end of the chord may be defined by a penetration into the interior of the ventricular wall rather than a passage completely there through. Complications associated with sealing and exterior attachment of the chord to the exterior of the ventricular wall are thereby eliminated.

As provided, the present invention further comprises a method of treating heart and valve malfunction utilizing the instrument as generally set forth above. Accordingly, the attendant method comprises, at least in more generic terms, the passing of a portion of the instrument assembly into an intended heart chamber and into penetrating relation to a predetermined valve leaflet, such as a prolapsing leaflet. The sheath, with the chord concentrically disposed on the interior thereof, is passed through the predetermined valve leaflet. Therefore, by virtue of the enclosed disposition of the chord, the chord and sheath will concurrently enter and extend through the predetermined valve leaflet. By manipulation and the application of a positioning force on the sheath, the sheath and the chord will extend across a corresponding heart chamber and into an anchored relation with a substantially opposing portion of the heart wall.

Once the anchor and the connected distal end of the chord are secured to the opposing heart wall portion, the sheath, still concentrically mounted exteriorly of and in enclosing relation to the chord, is withdrawn from heart chamber in which the chord is anchored. More specifically, the sheath is withdrawn by moving relative to and back along the length of the anchored chord in a direction away from the anchor and connected distal end of the chord. The introductory sheath is further withdrawn back through the predetermined valve leaflet while the proximal portion of the chord remains within the valve leaflet. Once the sheath is disposed exteriorly of the valve leaflet and possibly on the exterior of the heart itself, a securing assembly is operatively disposed within the heart chamber in interconnecting relation between a proximal extremity of the chord and the predetermined valve leaflet.

In more specific terms, the securing assembly may include a securing member, which will be mounted on or connected to a proximal portion of the chord and moved along the length thereof into a predetermined, interconnecting position relative to the prolapsing valve leaflet. The position of the securing member will be tailored to and disposed at the exact position needed to achieve correction of the mitral regurgitation, which may be determined by preoperative transoesopageal echography or other preoperative manner, to quantify the occurring mitral regurgitation preoperatively. The securing member then securely interconnects the proximal extremity of the chord to the predetermined valve leaflet and any excess length of the chord will be severed or detached from the proximal extremity of the chord, which is secured to the surface of the leaflet associated with the atrium. The chord is thereby properly tensioned between the opposing, interior corresponding wall portion of the heart and the predetermined valve leaflet so as to overcome the malfunction of the predetermined valve leaflet as explained in more specific details hereinafter.

As emphasized throughout this description, the instrument assembly and attendant method of the present invention is specifically adapted for the treatment of mitral regurgitation. As such, the introductory sheath and the chord, substantially concurrently enter the atrial wall of the left atrium and pass into the interior thereof. Further, the sheath and the chord penetrate and are passed, substantially concurrently, through a prolapsing (flail) anterior or posterior leaflet of the mitral valve into the left ventricle of the heart chamber. Thereafter the sheath and chord are concurrently extended transversely across the left ventricle, wherein the anchor penetrates and is thereby secured in an anchored relation with a substantially opposing portion of the ventricular wall and/or corresponding papillary muscles. The distal end of the chord is connected to the anchor and is thereby secured in an anchored relation to the ventricular wall, by virtue of the penetrating anchor.

Once the distal end of the chord and anchor are in the anchored relation to the ventricular wall, the sheath is withdrawn back along the length of the chord, away from the anchor and the ventricular wall to which the distal portion of the chord is secured. Moreover, the introductory sheath continues to travel back along the length of the chord through the prolapsing anterior or posterior mitral valve leaflet to a location at least exterior to the leaflet, such as within the left atrium and possibly exteriorly of the heart itself.

A securing assembly is then operatively associated with the instrument and is movably disposed along the length of a proximal portion of the chord. In even more specific terms, the movement of the securing assembly and its associated securing member are disposed into an interconnecting position between a proximal extremity of the chord and the mitral valve leaflet penetrated by the chord. As indicated above, proper tensioning is thereby placed on the prolapsing mitral valve leaflet in order to restore a sufficient surface of coaptation between its counterpart, opposing leaflet and maintain the suppressed leaflet in an operative position sufficient to overcome the mitral regurgitation.

Yet another preferred embodiment of the present invention is directed to an instrument assembly and attendant method for treating heart valve malfunction, including mitral valve regurgitation, wherein one of the mitral valves is prolapsing. As further described herein, the treatment procedure of this embodiment involves the positioning of a tensioning cord into the chamber of the heart, preferably through the left atrium. Moreover, the tensioning cord is preferably positioned, using a catheter, sheath and/or other positioning instrument such as, but not limited to, the type set forth above. More specifically, the chord will pass through the mitral valve, preferably through the mitral orifice and between the mitral valve leaflets, into the left ventricle. The distal end of the chord is anchored into the ventricular wall in a position generally opposing the mitral valve being treated. Concurrently, a proximal portion of the synthetic chord remains in a position through the mitral orifice exteriorly of the mitral valve, including at least a part of the proximal portion thereof being disposed in the left atrium.

In order to properly treat a prolapse of affected valve leaflet, the chord is connected to the valve leaflet by securing the proximal portion, more specifically the proximal end thereof to the predetermined mitral valve leaflet. In order to efficiently and effectively accomplish such attachment, this preferred embodiment of the present invention comprises a securing assembly structured to dispose a securing member in interconnecting relation between the proximal end of the chord and the predetermined valve leaflet. Accordingly, the securing assembly comprises a housing including a head portion and a base connected to the housing in a manner which facilitates relative movement of the head portion and the base between an open position and a closed position. Moreover, a capturing area is formed and/or disposed between the head portion and the base when they are in the open position. The disposition, dimension and configuration of the capturing area are such as to facilitate the gripping or other removable but secure engagement of the predetermined leaflet there between. As such, when “gripped” or otherwise removably retained between the head portion and the base as they are moved from the open position towards or into the closed position, the leaflet is disposed and maintained in a “connecting orientation”, as described in greater detail hereinafter. It is further emphasized that the term “closed position” is meant to describe the relative positions of the head portion and the base when they are gripping, engaging or otherwise removably but securely retaining the predetermined leaflet there between. Accordingly, it is recognized the closed position may be used to include the head portion and the base not being disposed in direct confronting or engaging relation to one another.

Additional details of the securing assembly include a positioning member, which may be in the form of a plunger or like structure, capable of being disposed in driving engagement with the head portion. As a result, manipulation of the housing to the extent of moving the positioning member it into a driving engagement with the head portion forces the head portion towards the base and into or towards the closed position and/or in gripping and removably retaining relation to the predetermined valve leaflet disposed within the capturing area. In order to facilitate return orientation of the head portion and base into the open position, when it is intended to release of the predetermined leaflet, a biasing structure is disposed to normally bias head portion into or towards the open position.

The securing assembly also includes a retaining assembly disposed on both the head portion and the base. As such, the retaining assembly is structured to removeably retain the securing member in a position which facilitates the connection of the securing member to the predetermined valve leaflet, before relative movement of the head portion and base and subsequently, as the head portion and base are relatively disposed from the open position and into or towards the closed position.

In more specific terms, the retaining assembly comprises first and second retaining segments each disposed on a different one of the head portion and base. Further, the first and second retaining segments are disposed and structured to removeably retain the first and second segments of the securing member, at least initially in spaced relation to one another, when the head portion and the base are in the open position. As also discussed in greater detail hereinafter, at least one embodiment comprises the first and second securing segments being respectively defined by a penetrating segment and a receiving segment. Therefore, when the penetrating and receiving segments are appropriately disposed in the first and second retaining segments, when in the open position, a proximal portion of the chord is connected to the base, as well as to the second retaining segment associated with the base. Accordingly, an “interconnecting relation” of the securing member relative to the predetermined leaflet comprises the penetrating segment disposed in penetrating relation through the valve leaflet, retained within the capturing area, when the head portion and base are disposed into the closed position.

Moreover, the accompanying method for treating mitral valve regurgitation using the instrument assembly, as generally set forth above, includes connecting the proximal portions of the chord to the securing member and the securing assembly, once the distal end of the chord is anchored in the ventricular wall. As indicated, when the distal end of the chord is anchored to the ventricular wall, the proximal portion of the chord will extend through the mitral orifice, between the valve leaflets, rather than penetrating through a valve leaflet, as with at least some of the preferred embodiments of the present invention, as described above. As such, the proximal portion of the chord is then connected to the valve leaflet by the securing member. Moreover, the proximal portion of the chord is connected to the securing assembly and the penetrating segment and the receiving segment are removably disposed within the corresponding first and second retaining segments, while the head portion and base are in the open position.

Accordingly, the chord will be properly tensioned and connected to the valve leaflet when its distal end is anchored to the ventricular wall and a proximal end of the proximal portion is connected to the predetermined valve leaflet. Such connection comprises the penetration of the penetrating segment through the predetermined valve leaflet and the receiving segment concurrently to the proximal end of the chord be being connected to the receiving segment and the base.

These and other objects, features and advantages of the present invention will become clearer when the drawings as well as the detailed description are taken into consideration.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature of the present invention, reference should be had to the following detailed description taken in connection with the accompanying drawings in which:

FIG. 1 is a perspective view of one preferred embodiment of the instrument assembly of the present invention used in the treatment of heart valve malfunction.

FIG. 1A is a perspective view of the instrument assembly of the embodiment ofFIG. 1 in an initially introductory position.

FIGS. 2 through 9 are schematic representations of successive steps in the attendant method of utilizing and applying the instrument assembly of the embodiment ofFIGS. 1 and 1A specifically for the treatment and correction of mitral regurgitation.

FIG. 10 is a schematic representation of yet another preferred embodiment of the present invention directed to a securing assembly for connecting a proximal end of a tensioned chord to a valve leaflet.

FIG. 10A is a sectional view in partial cutaway of a portion of the embodiment ofFIG. 10.

FIG. 11 is a schematic representation of the embodiment ofFIG. 10 in a successive, operative position.

FIG. 12 is a schematic representation of the embodiment ofFIGS. 10 through 11 in a successive operative position.

FIG. 13 is a schematic representation of the embodiment ofFIGS. 10 through 12 in a successive operative position.

FIG. 14 is a schematic representation of the embodiment ofFIGS. 10 through 13 in a successive operative position.

FIG. 15 is a schematic representation of the embodiment ofFIGS. 10 through 14 in a successive operative position.

FIG. 16 is a schematic representation of the embodiment ofFIGS. 10 through 15 in a successive operative position.

FIG. 17 is a schematic representation of another embodiment of the present invention similar to but distinguishable from the embodiment ofFIGS. 10 through 16.

FIG. 18 is a schematic representation of another embodiment of the present invention similar to but distinguishable from the embodiment ofFIGS. 10 through 16.

Like reference numerals refer to like parts throughout the several views of the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

As represented in the accompanying drawings and with specific reference toFIGS. 1 and 1A, the instrument assembly of the present invention is schematically and generally indicated as10 and is used for the treatment of heart valve malfunction generally and more specifically for the treatment of mitral regurgitation. As such, theinstrument assembly10 includes an elongated delivery catheter ortube12 having a hollow interior and structured to deliver operative portions of theinstrument assembly10 to the treatment site within the heart of a patient. As such, the elongated delivery catheter ortube12 is dimensioned and configured to enter the chest cavity through appropriate introduction instrumentation. Thedelivery tube12 is formed of a material and/or includes positioning structure or linkage incorporated therein which facilitates the maneuvering or steering thereof to a point at least generally exterior the heart and more specifically the atrial wall of the left atrium. However, the at least semi-rigid material of thedelivery tube12 should be sufficient to also facilitate proper manipulation so as to position or “steer” the remainder of theinstrument assembly10 to the intended location within the interior thereof, as well as facilitate penetration of and anchoring to intended tissue portions.

Theinstrument assembly10 also includes anintroductory sheath14 movable within thedelivery tube12 and an elongatedflexible material chord16. Theintroductory sheath14 is concentrically and movably enclosed within thedelivery tube12 and thesheath14 is movably disposed concentrically about thechord16. It is emphasized thatFIG. 1 represents a completely assembledinstrument assembly10. However, as will be described in detail with the schematic representations ofFIGS. 1 through 9, the various portions of theinstrument assembly10 are used in successive steps to accomplish installation relative to the affected portions of the heart valve being treated.

Accordingly, theinstrument assembly10 further includes the elongatedflexible material chord16 which may be formed of a synthetic, biocompatible material. Ananchor18 is fixedly secured to the outer or distal end of thechord16 and is movable therewith relative to theintroductory sheath14. As clearly represented inFIG.1A chord16 is at least initially enclosed concentrically within the interior of theintroductory sheath14, wherein thesheath14 is movable along the length of thechord16. Further, the sheath includes an opendistal end14′ serving to at least partially encloses or be registered alignment with theanchor18. Therefore,FIG. 1A represents cooperative portions of theinstrument assembly10 at least upon initial entry of theintroductory sheath14 andanchor18 into the interior of theheart30, as specifically described in detail inFIGS. 2 through 9, hereinafter described.

Therefore, with further regard toFIG. 1A, the positioning of theanchor18, theintroductory sheath14 and thechord16 is such that thechord16 is disposed within the interior of theintroductory sheath14. Further, theanchor18 is disposed at least partially within and/or in an exposed relation to the opendistal end14′ of thesheath14. In addition, theanchor18 has a sharpened, pointed or other appropriate configuration for penetrating portions of the heart. Theanchor18 may also include a grippingstructure20 which may be initially disposed in a collapsed position when theanchor18 is in registry with thedistal opening14′ of thesheath14. However, upon removal or exposure of theanchor18 and a length of thechord16 from an interior of thesheath14, the grippingstructure20 may include an inherent bias causing it to expand outwardly and/or radially from the remainder of theanchor18. This grippingstructure20 is provided to facilitate a secure engagement of theanchor18 with predetermined heart wall portions, when theinstrument assembly10 is properly applied in the treatment of the heart valve malfunction.

With further reference toFIG. 1 the assembled representation of theinstrument assembly10 further includes the provision of a securingmember22 which may travel along the length of thechord16. The securing member may be forcibly positioned into an intended interconnecting location relative to a heart valve leaflet in order to accomplish a secure attachment of thechord16 to the leaflet as will be explained in greater detail hereinafter. Such an interconnecting placement of the securingmember22 relative to both thechord16 and the affected valve leaflet serves to establish and maintain a sufficient tension and/or positioning force on the predetermined valve leaflet to suppress movement thereof, as explained hereinafter with regard toFIGS. 2 through 9.

As schematically represented inFIGS. 2 through 9, the heart is generally indicated as30 and includes the representative portions including theleft atrium32, theleft ventricle34 and themitral valve36, including the anterior and posteriormitral valve leaflets38 and38′, respectively. As additionally represented, theleft ventricle34 is at least partially bordered or surrounded byventricular wall40 which may be directly associated with corresponding papillary muscles (not shown) facilitating the proper positioning of themitral valve leaflets38 and38′ through organic tissue tethering, as generally outlined above.

For purposes of clarity,FIGS. 2-9 schematically represent theinstrument assembly10 used on theanterior leaflet38 of themitral valve30 in order to treat and correct mitral regurgitation. However, it is emphasized theinstrument assembly10 and the attendant method of the present invention may be applied to an anterior and/or the posterior prolapsing leaflet in the manner described herein, in correcting a mitral regurgitation condition of the heart. Moreover, while the various embodiments of the present invention are described using asingle chord16, a plurality ofchords16 may be used with the cooperative instrument components of theinstrument assembly10.

With initial reference toFIGS. 2 and 3, theinstrument assembly10 is introduced into the interior of theheart30 and more specifically into theleft atrium32, through theatrium wall33, using anappropriate introduction assembly42. Therefore, theintroductory sheath14 and thechord16 located concentrically within thesheath14 will concurrently pass through theatrial wall33 of the heart into theleft atrium32, as it is directed towards theanterior leaflet38 of themitral valve36. It should be further noted that theanchor18 is at least initially in the position generally represented inFIG. 1A. Due to its predetermined configuration theanchor18 will serve to approach and penetrate theanterior leaflet38 of themitral valve36 as clearly represented inFIG. 3.

In addition, the penetration of theanterior leaflet38 initially by theanchor18 will facilitate the penetration and passage, substantially concurrently, of thechord16 and theintroductory sheath14 through theanterior leaflet38 as schematically represented. As further represented inFIG. 3, a continued force will be applied to theintroductory sheath14 causing thesheath14 and interiorly disposedchord16, as well as theanchor18 to continue concurrent passage through theanterior valve leaflet38 until theanchor18 reaches, penetrates and is secured to theventricular wall40 and/or correspondingly disposed papillary muscles associated therewith.

As best represented inFIGS. 4 and 5, once theanchor18 is secured to theventricular wall40 and/or the corresponding papillary muscles, the distal end of thechord16 will be affixed to theventricular wall40 and remain in place as theintroductory sheath14 is withdrawn back along the length of thechord16, as indicated by the directional arrows. As theintroductory sheath14 is withdrawn back along the length of thechord16, the aforementionedgripping structure20 will have been expanded into a gripping orientation. When the grippingstructure20 is so oriented, theanchor18 and the distal end of thechord16 connected thereto will be reliably anchored or connected to theventricular wall40. Continued withdrawal of theintroductory sheath14 will result in its passage back through the initially penetrated and suppressedmitral valve leaflet38, as clearly represented inFIG. 5. As such, the majority of the length of thechord16 will thereby be exposed and maintained in the represented position within the left ventricle and between theventricular wall40 and the penetrated (suppressed)leaflet38, while theintroductory sheath14 passes back through theintroduction assembly42 and out of the interior of theleft atrium32, through theatrium wall33. Therefore, theproximal portion16′ of thechord16 remains in place, within theleft atrium32, and may serve effectively as a guide or otherwise facilitate the placement of the securingmember22, as represented inFIGS. 6 through 9.

More specifically, once theintroductory sheath14 is removed from theleft atrium32, through theintroduction assembly42, the securing assembly, including securingmember22, will move along the length of thechord16 as it is introduced into theleft atrium32 such as through the atrium wall via, theintroduction assembly42. As schematically represented, the securingmember22 will be forced, moved, positioned, etc. along the proximal portion orlength16′ of thechord16 by any appropriate technique and/or appropriate positioning instrument/device, which may be incorporated or operatively associated with thechord16. Positioning of the securingmember22 will continue until it is disposed in engaging, interconnecting and at least partially protective or sealing engagement with an exterior surface portion of the suppressed anteriormitral valve leaflet38 located within theleft atrium32. The position of the securingmember22 will be disposed in the exact position, on and along the length of thechord16 needed to position and or suppress movement of theleaflet38 to achieve correction of the mitral regurgitation. Such exact positioning may be determined by preoperative transoesopageal echography or other preoperative manner to quantify online mitral regurgitation preoperatively.

With further regard to the positioning of the securingmember22 into the interconnecting relation between the proximal extremity ofchord16 and theanterior leaflet38. One embodiment may also include a guiding element orsleeve25, as represented inFIG. 1. When utilized, theelement25 will be disposed at a predetermined position along the length on theartificial chord16 and be mounted concentrically about and/or along a portion of thechord16. As applied, the guidingelement25 may assume and or be at least partially defined by a variety of different structures, devices and/or mechanisms other than, but possibly including, the schematically represented sleeve. Accordingly, the guiding element is operative to accurately center or otherwise dispose the securingmember22 in sealing and/or covering relation to the aperture or area where thechord16 remains in its extended position through theanterior leaflet38. Further, the securingmember22 securely connects theproximal extremity16″ of thechord16 to thevalve leaflet38 and any excess length of theproximal portion16′ of thechord16 will be severed or detached from theextremity16″ of thechord16 and the securingmember22, which interconnects theproximal extremity16″ to the “exterior” surface of theleaflet38 exposed to theleft atrium32.

With continued reference toFIGS. 5 through 8, manipulation of the instrument of theassembly10, such as by medical personnel manipulating thedelivery catheter12 causes a severing of the proximal extremity from a remainder of thechord16. As a result, the securingmember22 serves to securely connect and fasten thechord16 to the exterior of theanterior leaflet38, disposed within theleft atrium32. Upon a secure connection of the securingmember22 to the exterior side or surface of theanterior leaflet38, theintroductory sheath14 passes back through theintroduction assembly42 so as to exit theleft atrium32 and the remainder of the heart. Thereafter, theintroduction assembly42 is also removed from its initial operative position.

Therefore, as represented inFIG. 9 theheart30 is represented with thesynthetic chord16 properly anchored between theventricular wall40 and the penetratedanterior leaflet38. In this position, proper tensioning or positioning forces are applied to theanterior leaflet38 causing it to be positioned in a manner which effectively overcomes mitral regurgitation, as set forth above.

As schematically represented inFIGS. 10 through 16, the present invention comprises yet another preferred embodiment directed to a securing assembly generally indicated as50. The securingassembly50 and its method of use is directed to the attachment of the proximal portion or proximal end of acord116, subsequent to it being anchored, as at18 in theventricular wall40 of theheart30. Similar to the embodiments represented inFIGS. 2 through 5, as set forth above, thesynthetic cord116 is operatively positioned within theleft ventricle34 by means of asheath14 or alternatively structured “spear” or like instrument introduced into theleft atrium32 through a heart wall,33 utilizing anintroduction assembly42. Theintroduction assembly42 may be, but is not limited to, the type of introduction assembly represented in the currently pending U.S. patent application Ser. No. 13/691,087 to the inventor herein. One distinguishing feature of the present invention includes the introduction of thecord116 into theleft ventricle34 through the mitral orifice and/or between the interior and posteriormitral valve leaflets38 and38′ respectively. This differs from the embodiments 2 through 5 wherein thesheath14 and/or substantially equivalent spear or like structure penetrates one of theleaflets38,38′ under treatment, such that a proximal portion of thecord16 extends through the predetermined leaflet under treatment.

Moreover, the securingassembly50 of this additional preferred embodiment of the present invention is intended to secure a securing member in attached, interconnecting relation between aproximal portion116′ or aproximal end116″ of thecord116 to the predetermined valve leaflet being treated. Accordingly, the securingassembly50 includes a housing generally indicated as52 having ahead portion54 and a base56 moveably disposed relative to one another between an open position, as represented inFIGS. 10 and 11 and a substantially closed position, as successively represented inFIGS. 12 and 13. In accomplishing the disposition of thehead portion54 andbase56 between the open and closed positions, a positioning member and/orplunger58 is mounted on and/or within thehousing52. As such thepositioning member58 is capable of being manipulated so as to force thehead portion54 from the open position, as represented inFIGS. 10 and 11, into the closed position, as generally represented inFIGS. 12 and 13. Therefore, the positioningmember58 may be in the form of a plunger type structure, which may be activated, controlled and/or operated by appropriate manipulation of theend53 or other appropriate portion of thehousing52.

It is of further note that thehousing50, including all of the operative and structural components associated therewith, is sufficiently dimensioned to pass through an appropriately disposed and dimensionedintroduction assembly42 of the type at least generally described above.

Other structural and operative features of the securingassembly50 includes a biasingstructure60 mounted on thehousing52 in substantially biasing relation to at least thehead portion54 and at least a portion of a retaining assembly generally indicated as62. As will be explained in greater detail hereinafter with regard to the method of use or operation of the securingassembly50, the retainingassembly62 includes afirst retaining segment64 connected to and moveable with thehead portion54, as well as asecond retaining segment66 connected to or mounted to thebase56. As such, retainingassembly62 is disposed on or connected to both thehead portion54 andbase56 is structured to initially and removeably retain a securingmember68 thereon. Moreover, the securingmember68, as used in combination with the securingassembly50, includes a multi-part structure, comprising a first or penetrating securingsegment70 and a second or receiving securingsegment72. Each of the first andsecond securing segments70 and72 is structured to assume an interconnecting relation between thecord116 and more specifically aproximal end116″ thereof and apredetermined valve leaflet100 involved in the procedure.

Yet additional features of the securingassembly50 includes a connectinglinkage74 mounted on thehousing52 and serving to moveably support at least thehead portion54 and structured for the movement of the positioning member orplunger58. As such, thehead portion54 and/orplunger58 are collectively disposed from the open position into the closed position.

In addition a severing or disconnectingmember76 is also mounted on the housing in interconnected relation to thehead portion54. The severing member is moveable with thehead portion54 when it is disposed between the open and closed positions. As described with specific reference toFIGS. 13 and 14, the disconnecting or severingstructure76 may include a severing blade or likemember78 connected to the severingstructure76 and moveable therewith and with thehead portion54 as it is forced by the positioning member orplunger58 from the open position ofFIGS. 10 and 11 into the closed position ofFIGS. 12 and 13. As indicated, theblade78 will serve to cut or otherwise disconnect a remainder of theproximal portion116′ of thecord116 from what may be accurately referenced to as aproximal end116″ of thecord116.

The primary reference toFIG. 10 A and as further represented throughout the remainingFIGS. 10 through 16, the base56 as well as connectinglinkage74 includes an at least partially slotted or apertured construction, such as at57 and75 respectively. Accordingly, prior to disposition of the first andsecond securing segments70 and72 in an interconnecting relation to both thecords116 andleaflet100, aproximal portion116′ of thecord116, including theproximal end116″, is connected to thebase56, receivingsegment72 and the connectinglinkage74. Such connection may occur by an at least partial “threading” thereof through the respective slots oropenings57,72′, and75 respectively. As clearly represented inFIG. 10A, the structure of thebase56, receiving securingsegment72 and the connectinglinkage74 may have an at least partially open, apertured or otherwise appropriately configured structure which facilitates the “threading” or other type of connection of theproximal portion116′ of thecord116 and/orproximal end116″ to and/or through thebase56, the receiving securingsegments72 and thelinkage74.

As represented throughoutFIGS. 1 through 16 and with reference toFIGS. 2 through 5 as well as11 through16, a method of use and/or application of the securingassembly60 may be directed to a method of treating a heart valve malfunction specifically including, but not limited to, the treatment of mitral valve regurgitation. As such, atensioning cord116 is introduced into the heart chamber through the left atrium and is directed through the mitral orifice to an anchored relation to theventricular wall34. Subsequent to the anchoring of the distal end, as at18, the proximal portion and/or more specifically, theproximal end116 Prime of thecord116 threaded or otherwise connected to thebase56, receiving securingsegment72 and a remainder of thehousing50 such as through the aperture orslot75 and the connectinglinkage74. Once thecord116 and/ordistal end116″ is connected in the manner described, theleaflet100, which may be under the siege of prolapse, is disposed in a connecting orientation, within the interior of a capturingarea80 between thehead portion54 and the base56 when in an open or at least partially open position. Hence, when thepredetermined valve leaflet100 is disposed in the connecting orientation, within the capturingarea80, thehousing52 or other appropriate portions thereof, such asend53, are manipulated to force the positioning member orplunger58 into driving relation to thehead portion54. This in turn will lower and/or dispose thefirst retaining segment64 into engaging, gripping and or at least partially clamping relation to thepredetermined valve leaflet100. Further forced downward travel of thehead portion54, through activation of theplunger58, will force the penetratingsegment70 of the securingmember68 into penetrating relation with thevalve leaflet100 and there through into connected, penetrating relation with the second or receivingsegment72, as clearly demonstrated in a comparison in theFIGS. 12 and 13. Once the securingmember68 is disposed in interconnecting relation between theproximal end116″ and thevalve leaflet100, as represented inFIG. 16, the securingassembly50 will be operated or manipulated to facilitate the disposition of thehead portion54 into the open orientation relative to thebase56, as clearly represented inFIGS. 14 and 15. Once in the open position, the securingmember68 upon selective movement into the closed position, will be positioned in penetrating relation to thevalve leaflet100 and will thereby be disposed into the interconnecting relation between thevalve leaflet100, theproximal end116″ and the interconnected penetrating and receivingsegments70 and72.

Therefore the interconnecting relation of the securingmember68 relative to thepredetermined valve leaflet100 will be such as to effectively grip and or sandwich it between the penetrating securingsegment70 and thereceiving securing segment72. As such, thedistal end116″ of thecord116 is also at least partially disposed in effectively connected relation with the penetratingsegment70 and receivingsegment72 as also clearly represented inFIGS. 15 and 16.

FIG. 17 represents yet another embodiment of the present invention, wherein the proximal portion of thechord116 is connected to thevalve leaflet100 so as to apply adequate tension thereto by passing between the penetrating and receivingsegment70 and72 respectively. As such, thedistal end116″ of thecord116 is not threaded through the receivingsegment72, as in the embodiment ofFIG. 16, but is clamped, gripped and/or sandwiched between the penetrating and receivingsegments70 and72 in interconnected, but not penetrating relation to theleaflet100.

FIG. 18 schematically represents yet another embodiment of the securingmember168 comprising a clip-like structure includingfirst segment170 and asecond segment172 movably connected as by an integral connection and/orappropriate hinge portion174. In this embodiment, the securingmember168 is operable to clamp theproximal end116″ of the proximal portion of the tensioning chord to theleaflet100 as the proximal end is sandwiched between the first andsecond segments170 and172, when they are in a closed relation to one another and gripping or clamping engagement with the leaflet. Moreover, the material from which the securingmember168 is formed is structured to remain in the closed relation and gripping or clamping engagement with theleaflet100 andproximal end116″, when a closing or gripping force is applied thereto as schematically represented bydirectional arrows104.

In addition, the securingmember168 can be disposed in the aforementioned closed relation or gripping engagement relative to theleaflet100 andproximal end116″ by the securingassembly50, substantially as described above, with little or no structural or operational modifications be required.

Since many modifications, variations and changes in detail can be made to the described preferred embodiment of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents.

Now that the invention has been described,

Claims (12)

What is claimed is:

1. An instrument assembly for treating heart valve malfunction by securing a chord, pre-anchored at a distal end thereof to a heart, to a valve leaflet of the heart under sufficient tension to restrict prolapsing of the valve leaflet, said instrument assembly comprising;

a securing assembly structured to dispose a securing member in interconnecting relation between a proximal portion of the chord and the valve leaflet,

said securing assembly including a head portion and a base relatively disposable between open and closed positions and structured to retain said securing member in an operative position,

said securing assembly structured to moveably retain said chord relative to said securing member, a position of said securing assembly relative to the distal end of the chord varying an operative length of the chord,

a capturing area disposed between said head portion and said base, at least when said head portion and said base are in said open position,

said capturing area configured to receive and removably retain the valve leaflet therein in a connecting orientation to said securing member, and

said securing member being structured to penetrate and pass through the valve leaflet into said interconnecting relation between the chord and the valve leaflet when said head portion and said base are disposed into said closed position, and

a severing member connected to and moveable with said securing assembly, said severing member disposable in severing relation to a proximal portion of the chord concurrent to disposition of said head portion and said base into said closed position and interconnection of said proximal portion of the chord with said securing member.

2. An instrument assembly as recited inclaim 1 further comprising a positioning member movable with said head portion between said open and closed positions.

3. An instrument assembly as recited inclaim 2 wherein said positioning member is connected to a housing and disposed in driving relation to said head portion when moving from said open position to said closed position.

4. An instrument assembly as recited inclaim 2 further comprising a biasing structure disposed to normally bias said head portion from said open position to said closed position.

5. An instrument assembly as recited inclaim 1 further comprising a retaining assembly disposed on both said head portion and said base and structured to removably retain the securing member in predetermined relation to the valve leaflet, at least prior to disposition of said securing member into said interconnecting relation.

6. An instrument assembly recited inclaim 5 wherein said retaining assembly comprises a first retaining segment, disposed on the head portion and disposed and structured to removably retain and position a first securing segment into said closed position, and a second retaining segment, disposed on the base and disposed and structured to removably retain and position a second securing segment into said closed position.

7. An instrument assembly recited inclaim 6 wherein at least one of said first and second retaining segments is structured to receive the chord in connected relation thereto and to a corresponding one of the first or second securing segments.

8. An instrument assembly recited inclaim 6 wherein said first retaining segment is connected to said head portion and structured to position said first securing segment into said closed position; said second retaining segment connected to said base and structured to position said second securing segment into said closed position; wherein said first securing segment comprises a penetrating segment; and wherein said second securing segment comprises a receiving segment.

9. An instrument assembly recited inclaim 8 wherein said penetrating segment is structured to be disposed in penetrating relation through the valve leaflet retained within said capturing area when the securing member is in said interconnecting relation.

10. An instrument assembly recited inclaim 8 wherein said penetrating segment and said receiving segment are structured to be disposed in interconnecting relation to said chord and the valve leaflet when the securing member is in said interconnecting relation.

11. An instrument assembly recited inclaim 8 wherein the chord is structured to be connected to the valve leaflet substantially between said penetrating and receiving segments when the securing member is in said interconnecting relation.

12. An instrument assembly for treating heart valve malfunction by securing a chord, that has a distal end thereof pre-anchored to a heart, to a valve leaflet under sufficient tension to restrict prolapsing of the valve leaflet, said instrument assembly comprising:

a chord having a distal end disposable in anchored relation with a heart,

a securing assembly structured to dispose a securing member in an interconnecting relation between a proximal portion of the chord and the valve leaflet,

said securing assembly including a head portion and a base relatively disposable between open and closed positions and structured to removably retain said securing member in an operative position, said securing member being within said securing assembly prior to said securing member being disposed in said interconnecting relation,

said securing assembly structured to moveably retain said chord relative to said securing member during positioning of said securing member, a position of said securing assembly relative to the distal end of the chord setting an operative length of the chord at the securing member,

said base comprising a slot or aperture, the chord passing through the base via the slot or aperture for movably retaining said chord relative to said securing member during positioning of said securing member,

a capturing area disposed between said head portion and said base, at least when said head portion and said base are in said open position,

said capturing area configured to receive and removably retain the valve leaflet therein in a connecting orientation to said securing member,

said securing member being structured to penetrate and pass through the valve leaflet into said interconnecting relation between the chord and the valve leaflet without varying said operative length of the chord set by said securing assembly when said head portion and said base are disposed into said closed position,

a positioning member movable with said head portion between said open and closed positions,

a connecting linkage mounted on the securing assembly, and structured for disposition of the positioning member and head portion between the open and closed positions,

said connecting linkage comprising a partially slotted or apertured construction for movably retaining said chord relative to said securing member during positioning of said securing member.

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